<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
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    <udiDi>06975358885217</udiDi>
    <basicUdiDi>B-06975358885217</basicUdiDi>
    <tradeName>06975358885217</tradeName>
    <deviceName>PCR-CE DMD gene Kit</deviceName>
    <manufacturerName>Xiamen Biofast Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000027220</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0106010102</emdnCode>
    <emdnDescription>DUCHENNE MUSCULAR DYSTROPHY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>04110006</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:29:36.227Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975358885200</udiDi>
    <basicUdiDi>B-06975358885200</basicUdiDi>
    <tradeName>06975358885200</tradeName>
    <deviceName>PCR-CE DMD gene Kit</deviceName>
    <manufacturerName>Xiamen Biofast Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000027220</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0106010102</emdnCode>
    <emdnDescription>DUCHENNE MUSCULAR DYSTROPHY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>04110005</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:29:35.425Z</lastUpdated>
  </row>
</eudamedExport>